Sr. Quality Assurance & Regulatory Affairs Manager

About the Job

The Regulatory Affairs and Quality Assurance Manager will provide Quality Management, Regulatory and Quality Engineering expertise, direction and hands-on involvement regarding quality processes, biomedical regulatory affairs, and systems to drive continuous improvement in support of quality and compliance objectives. This position reports to the Global RA/QA Director.

This a full-time, exempt position based in Everett, WA. Fluke Health Solutions offers competitive salary, time off and benefits. Our offering includes PTO, paid holidays, medical/dental/vision on Day 1 + many more. Bring your whole self to FHS!

Responsibilities

• Leads and participates in formal problem-solving processes, conducts root cause and corrective action investigations for quality failures, including those occurring in supplier, in-house processes and Client-side findings.

• Supports the Director, RAQA for all Quality and Regulatory strategy plans, actions, implementation and upskilling as the Business grows.

• Leads overall site compliance efforts, including, but not limited to:

• Support for regulatory meetings with FDA.

• External health authority inspections and audit readiness and logistics.

• Front room audit host, RA/QA Subject Matter Authority, and/or backroom support.

• Key liaison for agency communications as the need arises.

• Lead followup activities for post-inspection root cause and correction action plan for identified corrections.

• Completion of essential functions includes the effective application of: Gage R&R Studies, Design of Experiments, Failure Mode and Effects Analysis, Statistical Process Control, the determination of Operating Characteristics for Sampling Plans, and statistical analysis to effect quantifiable product and process improvements.

• Fulfills QA/RA subject matter authority role for all functional areas.

• Maintains Risk Management conformance to 14971 requirements, including governance of risk tools such as FMEA, Hazard Analysis, Risk-Benefit, etc.

• Drives effective and efficient improvement of inspection and test methods, sampling plans, and process control plans.

• Prepares and conducts training sessions and presentations in support of quality objectives.

• Actively participates in new product development teams and sustaining design change activities and fulfills RA/QA required actions.

• Lead the site CAPA system and ensure effective CAPA Review Board.

• Lead all aspects of the Complaint system for timely complaint handling and MDR reporting ability.

• Maintains applicable licenses and registrations to support global market.

• RA/QA review for customer-facing marketing materials per FHS processes.

• Supports all facets of the internal audit system including scheduling, auditing, reporting, and corrective actions.

• Supports all facets of the supplier qualification and audit system including scheduling, auditing, reporting, and corrective actions with follow-ups.

• Maintains a professional working relationship with internal and external customers and support staff.

• Provide metrics to Leadership for overall compliance initiatives and report on health of the QMS.

• Actively lead, support, mentor and develop RA/QA team members and others as needed.

• Provide resource assignments across team members to support all cross functional business activities.

Qualifications

• Bachelor's degree (B.S. or equivalent experience) in engineering or science field from a four-year college or university.

• Consistent track record to lead, grow in a Leadership position, and enable Team members to grow as well.

• Minimum of seven years' experience in Quality Assurance and three years' experience in Regulatory Affairs in an FDA regulated industry.

• Four year's people management experience. Track record of building and leading high-performance teams.

• Working knowledge of Quality Management Systems -. 21 CFR Part 820, ISO 9001/13485, ISO 14971, ISO 17025 in development and manufacturing environments.

• Marked ability to learn new applicable standards, resolve how they apply to the Business and provide related guidance cross-functionally.

• Strong interpersonal skills with the ability to be a standout colleague and Leader; setting a professional tone and establishing a collaborative partnership within the department and other areas of the Company to optimally resolve problems.

• Ability to interpret trends and data, translating the information into actions, outcomes, and improvements.

• Excellent documentation skills, with a proven process orientation and effective attention to detail.

Fortive Corporation Overview

Fortive's essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We're a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

At Fortive, we believe in you. We believe in your potential-your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

Fortive: For you, for us, for growth.

The salary range for this position (in local currency) is 122,000.00 - 226,600.00. Base pay offered may vary depending on various factors, including, but not limited to: job-related knowledge; skills; experience; and other eligibility factors such as geographic location. The Total Rewards package includes competitive base pay and an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and several programs that provide for both paid and unpaid time away from work.

We are an Equal Opportunity Employer

Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at ~~~.